QA Validation technician and CSV

We are looking for a new “QA/CSV Specialist” who will offer service to a multinational pharmaceutical company.

🌐 Sant Cugat (Barcelona)

TASKS 🚀:

  • Support the team in order to ensure that processes within computerized systems (e.g. ERP (SAP), Trackwise)
    are implemented and used in a compliant manner (GxP) following internal and external regulations.
  • Approval of System Life Cycle documentation in compliance to the respective validation methodology.
  • Support deployment according to the BI internal standard method.
  • Ensure audit readiness and supports regional audits of systems in scope of the position.
  • Regional interactions with all relevant business units (i.e. Production sites and commercial sites) and Global Functions, as well as cross functional project teams.
  • Support the handover of quality tasks to the run organization.
  • Support that further externals which supporting other internal department(s) are working under the agreed methodology.
  • Guides and defines work packages for external support and monitors the quality of deliverables.
  • Partner with and educate business stakeholders and cross functional project teams through coaching and education regarding the need for compliance with regulations and quality management processes.
  • Manage existing/additional SOPs where applicable.

SKILLS 🤹:

  • Profound experience in a GxP regulated environment with focus on quality assurance and business process expertise.
  • Knowledge on Computer System Validation, cGMP regulations and pharmaceutical QA systems –
    including external regulations e.g. EU-GMP Guideline, Annex 11, 21 CFR Part 11, Data Integrity requirements and internal regulations.
  • Speak-up mentality/ ability to challenge and make judgment calls with Senior Management.
  • Ability to prioritize and to effectively manage multiple tasks at the same time, quickly respond to changing internal and external requirements.
  • Respect and understanding of cultural diversities across the area of responsibility.
  • Fluent in English.

SCHEDULE 🕘:

  • From monday to friday: 08am to 5pm / 09am to 6pm (flexible)
  • During COVID – Full time remote.
  • After COVID – Mandatory minimum 3 days of office work.

CONDITIONS 🌱:

  • Salary package based on your profile.
  • Food expenses and Ticket restaurant included in-office hours.
  • Flexible compensation plan (free of income tax) where we provide you with medical insurance, public transport ticket and childcare check.
  • Discounts on physiotherapy center and gym network.
  • Training catalogue.

Our goal is that you are well in every way!

Are you interested?
Apply for information.

 

Do you know someone who might be interested in this offer? Share!

Share on facebook
Share on twitter
Share on linkedin
Share on whatsapp
Latest offers